Phase
Condition
Neuropathy
Polymyositis (Inflammatory Muscle Disease)
Sarcopenia
Treatment
DNTH103
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must have given written informed consent before any study-related activities arecarried out.
Adult males and females, 18 to 75 years of age (inclusive) at Screening.
Weight range between 40-120 kg at Screening.
Diagnosis of gMG by the following tests: Acetylcholine receptor antibody (AChR Ab) positive, and One of the following: i. History of abnormal neuromuscular transmission test; ii. History of positiveanticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, andwhere available, meningococcal serotype B vaccine within 3 years prior to, or at thetime of, initiating study drug.
Female participants must: Be of non-childbearing potential, or if of childbearing potential, must agree not todonate ova, not to attempt to become pregnant and, if engaging in sexual intercoursewith a male partner, must agree to use a highly effective method of contraception.
Male participants must be surgically sterile for at least 90 days prior to screeningor agree not to donate sperm
Exclusion
Exclusion Criteria:
History or presence of significant medical/surgical condition including any acuteillness or major surgery considered to be clinically significant
Prior history (at any time) of N. meningitidis infection.
Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2),hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies duringScreening.
Any thymic surgery/biopsy within 1 year of Screening.
Any known or untreated thymoma.
Any history of thymic carcinoma or thymic malignancy.
Concurrent or previous use of the following medication within the time periodsspecified below.
Rituximab within 6 months (180 days) prior to randomization (Day 1);
Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28days) prior to randomization (Day 1).
Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.
Study Design
Study Description
Connect with a study center
Clinical Study Site
San Miguel de Tucuman, Tucuman T4000
ArgentinaSite Not Available
Clinical Study Site
Buenos Aires, C1015ABR
ArgentinaSite Not Available
Clinical Study Site
Cordoba, X5004CDT
ArgentinaSite Not Available
Clinical Study Site
Rosario, 2000
ArgentinaSite Not Available
Clinical Study Site
London, Ontario N6A 5W9
CanadaSite Not Available
Clinical Study Site
Ostrava, 70852
Czech RepublicActive - Recruiting
Clinical Study Site
Ostrava, 70852
CzechiaSite Not Available
Clinical Study Site
Copenhagen, 02100
DenmarkSite Not Available
Clinical Study Site
Bordeaux Cedex, 33076
FranceSite Not Available
Clinical Study Site
Nice, 06001
FranceSite Not Available
Clinical Study Site
Strasbourg, 67000
FranceSite Not Available
Clinical Study Site
Haifa, 3109601
IsraelSite Not Available
Clinical Study Site
Ramat Gan,
IsraelSite Not Available
Clinical Study Site
Rambam, 3109601
IsraelSite Not Available
Clinical Study Site
Zefat, 13100
IsraelSite Not Available
Clinical Study Site
Milano, 20133
ItalySite Not Available
Clinical Study Site
Napoli, 80131
ItalySite Not Available
Clinical Study Site
Pisa, 56126
ItalySite Not Available
Clinical Study Site
Rome, 00168
ItalySite Not Available
Clinical Study Site
Skopje, 1000
Macedonia, The Former Yugoslav Republic ofActive - Recruiting
Clinical Study Site
Amsterdam,
NetherlandsSite Not Available
Clinical Study Site
Skopje, 1000
North MacedoniaSite Not Available
Clinical Study Site
Bergen, 5021
NorwaySite Not Available
Clinical Study Site
Bydgoszcz, 85-065
PolandSite Not Available
Clinical Study Site
Katowice, 40123
PolandSite Not Available
Clinical Study Site
Krakow, 31-503
PolandSite Not Available
Clinical Study Site
Kraków, 31-202
PolandSite Not Available
Clinical Study Site
Kralkow, 31-503
PolandSite Not Available
Clinical Study Site
Lublin, 20-093
PolandSite Not Available
Clinical Study Site
Warsaw, 02-657
PolandSite Not Available
Clinical Study Site
Belgrade, 11000
SerbiaSite Not Available
Clinical Study Site
Kragujevac, 34000
SerbiaSite Not Available
Clinical Study Site
Nis, 18000
SerbiaSite Not Available
Clinical Study Site
Novi Sad, 21000
SerbiaSite Not Available
Clinical Study Site
Malmö,
SwedenSite Not Available
Clinical Study Site
Phoenix, Arizona 85028
United StatesSite Not Available
Clinical Study Site
Irvine, California 92868
United StatesSite Not Available
Clinical Study Site
Stamford, Connecticut 06905
United StatesSite Not Available
Clinical Study Site
Boca Raton, Florida 33487
United StatesSite Not Available
Bradenton Research Center
Bradenton, Florida 34205
United StatesActive - Recruiting
Clinical Study Site
Bradenton, Florida 34205
United StatesSite Not Available
Research Site
Bradenton, Florida 34205
United StatesActive - Recruiting
Clinical Study Site
Maitland, Florida 32751
United StatesSite Not Available
Clincal Study Site
Tampa, Florida 33620
United StatesSite Not Available
Clinical Study Site
O'Fallon, Illinois 62269
United StatesSite Not Available
Clinical Study Site
Kansas City, Kansas 66103
United StatesSite Not Available
Clinical Study Site
Lexington, Kentucky 40503
United StatesSite Not Available
Clinical Study Site
Boston, Massachusetts 02215
United StatesSite Not Available
Clinical Study Site
East Lansing, Michigan 48824
United StatesSite Not Available
Clinical Study Site
Columbia, Missouri 65212
United StatesSite Not Available
Clinical Study Site
Cincinnati, Ohio 45219
United StatesSite Not Available
Clinical Study Site
Columbus, Ohio 43221
United StatesSite Not Available
Clinical Study Site
Dallas, Texas 75243
United StatesSite Not Available
Texas Neurology
Dallas, Texas 75206
United StatesActive - Recruiting
Clinical Study Site
Houston, Texas 77030
United StatesSite Not Available
Clinical Study Site #2
Houston, Texas 77030
United StatesSite Not Available
Nerve And Muscle Center Of Texas (NMCT)
Houston, Texas 77030
United StatesActive - Recruiting
Clinical Study Site
Lubbock, Texas 79414
United StatesSite Not Available
Research Site
Lubbock, Texas 79414
United StatesActive - Recruiting
West Texas Neurology Clinic
Lubbock, Texas 79414
United StatesActive - Recruiting
Clinical Study Site
Richmond, Virginia 23219
United StatesSite Not Available
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